MHRA Double standards on vitamin B12 injections

So far, B12 injections can’t be bought from a pharmacy in the UK by the general public, but can be bought from a hair or beauty salon or any one of the 2500 technicians, clinics or outlets in the UK at a cost of between £25 – £100 each.

Isn’t this odd?- And some would say ridiculous or even immoral.

 

Following on from my previous blog regarding the B12 OTC Petition and the future Westminster Hall debate which my MP Jane Hunt will apply for – some of you kind people have asked your MP to join Jane and also make supporting speeches. Some MP’s have said, “I would need some compelling evidence to agree to do this.” – As if being restricted to just 4 lifesaving, cheap, injections a year isn’t compelling enough?

Well, the following information may help your MP to act – but if it doesn’t, then goodness knows what will and I suggest you get yourself a new one as soon as possible!

Find your MP here: FindYourMP and perhaps send this blog post to them?

Now here’s the funny bit

The MHRA in responding to our petition stated:

“……Vitamin B12 could not legally be classified as a medicine that can be made available for sale without prescription in pharmacies because it is an injection and because the condition it is licensed to treat, pernicious anaemia, needs a clinician  to diagnose it, and monitor its treatment (see point IV above). The same applies to insulin injections and to the diagnosis and monitoring of treatment of diabetes.
Vitamin B12 injection is currently licensed for use in maintenance therapy for pernicious anaemia every 2 – 3 months depending on the type of pernicious anaemia. Even if the product could be reclassified to make it available for sale in pharmacies, it could not be used more frequently than every 2 – 3 months, so reclassification to a Pharmacy medicine would not help those who require more frequent injections.”

and then they also state:

“Our current advice to private clinics administering vitamin B12 injections which are not licensed medicinal products intravenously for non-medicinal purposes is that we do not regard these to be medicines and that they fall outside of the remit of the MHRA. It must be absolutely clear in the advertising of such products that they do not have a medical purpose.”

So the same B12 (hydroxocobalamin in this case), from the very same manufacturers, is at the very same time;

A licensed medicinal product and also a non-medicinal product.

Mad, maddening and hilarious all at the same time isn’t it?

Slaps on the wrist

Some enterprising B12 injection providers have been telling the general public the truth, that B12 injections help boost immunity, that they combat fatigue and they may therefore help against COVID but the MHRA’s ludicrous rules around non-medicinal products which are also POM’s mean these statements do not comply and in fact telling the truth is a BIG FAT NO NO.

The MHRA have spent time during COVID alongside the ASA (Advertising Standards Agency) warning people who sell B12 injections direct to the public through beauty salons and the like – that they absolutely must not tell those they advertise to, what B12 injections will do or what they can help with.

12th June 2020

The MHRA allows clinics and individuals to market B12 injections by using the words ‘wellness’ or ‘boost’ or ‘supplement’ but not ‘deficiency’, they absolutely cannot be marketed with medical claims, and this is the bit that makes NO SENSE whatsoever, because we with B12 deficiency keep being told they are a ‘Prescription Only Medicine’!!!!!!

Please see below;

In May, the MHRA and the ASA published an Enforcement Notice which makes clear to businesses which offer vitamin shots the nature of the rulings and directs them to remove any COVID-19 related claims from their websites and social media pages. 

The following sets out and details these most recent regulatory developments:

  •  Prescription-only medicines (POMs) cannot be advertised to the public. 
  • Injectable vitamin D and injectable vitamin B12, specifically, are prescription-only medicines 
  • Advertisers must not, directly or indirectly, promote POMs to the public. Targeted enforcement, with the aid of monitoring technology, to find problem ads for removal and sanction came into effect on 12 June 2020. It also states this applies to ads for all “vitamin shot” products, not just vitamin D or vitamin B12. 
  • Action against direct and indirect claims that vitamin shots could help treat or prevent COVID-19

B12 Clinics

Like anything in this world there is good and not so good practice. Some clinics and individuals selling B12 injections direct to the public are stringently trained and follow their company’s guidance to the letter, keeping good records.

If they find a potential client is severely B12 deficient but has not been diagnosed and needs to be referred to a GP, they will explain this without skewing chances of diagnosis by not giving a B12 injection. Others won’t, they simply may not know that diagnosing B12 deficiency for the person is key to being able to access B12 from their GP as there is usually a lifelong need and having regular B12 injections from a private clinic would may not be financially sustainable.

A lifeline

These clinics and technicians provide an essential lifeline for so many who are dragging themselves around trying to survive on one injection every three months whilst trying to function, keep their mental health on track, look after a family, hold down a job and who may have had to home school on top of everything else during this years lockdowns.

They also provide a lifeline to the many patients who are B12 deficient but remain untreated due to a within range result on a serum B12 test. Too many GP’s do not understand the limitations of the test and that the clinical picture of B12 deficiency is of utmost importance. Some are unwilling to budge and allow treatment even when faced with a tearful patient on their knees begging for treatment.

Although my remit with my website is to keep people under the care of their GP when possible, I have referred people to the services of B12 clinics and technicians. This has occured when people are desperately ill and haven’t the strength or the inclination to battle with their GP for correct treatment. This has meant that these trusted sources can give the first injection and also teach the patient to self inject prior to purchasing their own supplies from pharmacies in other countries for around 60p per ampoule.

BREXIT

The awful truth is that the opportunity to buy from abroad has narrowed with BREXIT so now the situation is even more URGENT. We need B12 injections to be made available OTC from pharmacies in the UK so that when there is no help from the GP and where costly private injections are not an option, that people can access vital treatment.

Let’s not forget that the BSH sent out harmful Guidance stopping essential B12 injections which they then had to amend. Some GP’s Practices proudly report they are moving more and more patients onto tiny and useless 50mcg cyanocobalamin tablets unless they have a diagnosis of pernicious anaemia. This ludicrously harmful practice needs to be reversed. It needs to be shouted from the roof tops that PA is JUST ONE OF MANY CAUSES of B12 deficiency. It is NOT more serious than any other cause and apart from a deficiency caused by a proven dietary lack, treatment by injection is required for the swiftest recovery.

MHRA Threat to clinics

In communication with the MHRA, they also stated:

“However, we do have concerns about the level of clinical oversight present in IV vitamin therapy and injection services in general and the appropriacy of such services is currently under review.”

This ‘review’, if deciding on stopping treatment of B12 injections by clinics who do comply with the ridiculous rules of the MHRA, would not only negatively impact the companies and individuals who give B12 injections, but also to the people who rely on them to keep functioning both physically and mentally.

Don’t want to self inject?

There will always be people who do not wish to give themselves B12 injections and I for one hope that pharmacies would offer a service to people afraid of self administration.
Since embarking on the petition to make B12 OTC, some have commented that they fear that GP’s might stop giving B12 altogether if successful. I feel this fear is unfounded, doctors in countries who do allow OTC still prescribe and administer B12 injections to patients who need them. It would remain the responsibility of Primary Care to diagnose and treat B12 deficient patients but they would have to choose to.

Why do we need B12 to be made OTC?

Because so many people are restricted to just one lifesaving B12 injection once every three months. Some people say they can cope on this regime but many of us can’t, myself included. Each of us is differently affected and require a different frequency of B12 injections.

Whilst many GP’s will not treat patients according to individual need (or feel their hands are tied), then it is essential to allow patients the ability to look after themselves.

Please, if you feel strongly on this issue, ask your MP to get involved.

When rules are harmful, discriminating and ridiculous they need to be changed. Surely the MHRA can make vital lifesaving B12 injections available over the counter if they want to?

Wishing you the very best for 2021.

I hope that together we can reach this joint goal, along with freedom, togetherness and peace.

Tracey x
www.b12deficiency.info

 

 

 

Petition update – Your help is needed for the next stage!

Petition response

We’ve had a response to our petition from the Department of Health and unfortunately they have reported what we already know about the regulations for a POM (Prescription only medicine).

They state that we can’t have injectable B12 made available from pharmacies in the UK because of the Human Medicines Regulation 62 section 3.

Westminster Hall Debate

This doesn’t mean we give up. This means we keep on going and thankfully My MP, Jane Hunt is committed to helping and will be making an application for a debate on our petition in Westminster Hall. The focus of this will be that the MHRA allow B12 injections to be given as a boost via hair salons and clinics. More on this in the next blog.

Your MP can help

We need your MP to speak for you, alongside Jane when this happens.

Please ask your MP to come on board, to make a speech on your behalf and get in touch with Jane so that they can work together on this.

Find your MP here: https://members.parliament.uk/FindYourMP

So if you feel strongly about being in control of your own health …

If you have had B12 injections stopped due to COVID…

If you are restricted to 3 monthly injections but need them more frequently…

If you feel you have no choice but to buy B12 from abroad because you can’t access what you need from your GP then please help to make this happen…

Here’s how you can help

I’ve added a draft email for you to use and adapt below so that you can easily send a message to ask your MP to help. It would be lovely to hear of their interest in this, so if possible please let me know by commenting on the blog.

Thank you so much for being part of this, I feel sure that if we keep working together we can make this important change happen.

Together I’m sure we can make this happen.

Kindness always

Tracey Witty

www.b12deficiency.info

Draft email 

Dear

Please can I ask for your support in making injectable vitamin B12 available OTC from pharmacies.

Following a reading of this petition at the House of Commons on the 23rd of September 2020 the Department of Health responded: They state that we can’t have injectable B12 made available from pharmacies in the UK because of the Human Medicines Regulation 62 section 3.

Jane Hunt MP is making an application for a Westminster Hall Debate on this petition and she needs your help.

This issue is really important to me because………………………….

Please contact Jane Hunt MP ( jane.hunt.mp@parliament.uk ) and get involved on my behalf.

Yours faithfully

If you can’t copy the above please find a copy of the text here

 

 

Fingers crossed…

For anyone who didn’t catch the presenting of the petition last night please see this link 

MP Jane Hunt, did an amazing job for us in summarising the written petition, the text from which I add below, but it can also be viewed on Hansard here.

This was not the Change.org Petition
To clarify, this was an entirely new Government Petition signed by me and Damian as it was being presented by Jane who is our MP.
It was however really important to mention the 94,000 signatures we have already garnered from the Change.org petition so that the strength of feeling was demonstrated.

Here’s the full wording:

Petition: Removing classification of Prescription Only Medicine from injectable vitamin B12

To the House of Commons.

The petition of the residents of the constituency of Loughborough.

Declares that a lack of B12 can have far reaching and significant effects on both physical and mental health; notes that a significant number of people who are B12 deficient are unable to absorb the vitamin from food or supplements, and so need to inject it, which they can only do at their GP practice; further notes that NICE CKS guidance states that treatment of B12 deficiency in people with neurologic involvement should include injections on alternate days until there is no further improvement; further notes that a restricted maintenance dose of just four injections per year is what is normally allowed, which can leave people physically and mentally unable to contribute to either family or society, and lead to permanent neurological damage; further notes that, in response to a Freedom of Information request asking for the clinical evidence for the three monthly maintenance dose, the Medicines and Healthcare products Regulatory Agency stated that they were unable to obtain this information; further notes that B12 injectables should be made available over the counter at pharmacies, which would bring our approach in line with that of other countries, affording those with B12 deficiency the same dignity and control over their own health as a diabetic using insulin, and reducing the workload and financial burden on GP practices, District Nurses and other NHS services; further notes that a Change.org petition started by the petitioners on this issue has garnered over 94,000 signatures.

The petitioners therefore request that the House of Commons urges the Government to remove the classification of Prescription Only Medicine from injectable vitamin B12.

And the petitioners remain, etc.

 

Now all we can do is hope and wait for a positive response that will give us the ability to treat ourselves according to our own individual need.

I will keep you updated!

Kindness always
Tracey x

www.b12deficiency.info

Thank YOU for your kindness in sharing this post. You can buy your “B12 for life” campaign pin here.

 

 

 

 

B12 Awareness Day 2020 In the House of Commons

I am delighted to announce that MP Jane Hunt will present a petition to the House of Commons today, Wednesday the 23rd of September 2020, which asks for injectable vitamin B12 to be made available over the counter from pharmacies.

Please note this is my New Government Petition and NOT the Change.org petition.

If your MP also has an interest in this issue, please ask them to come on board and help us to get this passed.

Jane is scheduled to present the petition titled “Removing classification of prescription only medicine from injectable vitamin B12,” at the end of the day just before the adjournment debate, usually around 7pm. There is no precise time yet but you will be able to watch it live on Parliament TV or on BBC Parliament.

The full petition text will be also posted on House of Commons Hansard and the Government will need to respond to it. Too many people are restricted to just four vitamin B12 injections per year which is not enough to heal damaged nerves.

All we can do now is sit and wait for a positive outcome which would bring us into line with many other countries who do allow injectable B12 to be purchased over the counter. This has the potential to make treatment of vitamin B12 deficiency free from stress and anxiety for millions of UK citizens, affording us the same level of dignity and control over our own health as a diabetic injecting insulin.

Huge thanks to everyone who has supported this movement and to MP Jane Hunt and her team for making this possible and for for caring about people with B12 deficiency.

I have everything crossed and I’m you sure you do too.

Kindness always

Tracey x
www.b12deficiency.info

Thank YOU for your kindness in sharing this post. You can buy your “B12 for life” campaign pin here.

 

#ProtectTheNHS #SaveLives and #MakeB12OTC

Making injectable B12 available over the counter from pharmacies will help save lives and will help to save money and time for the NHS.

You may have been denied your B12 injections due to COVID 19.

You may have failed to achieve a diagnosis due to your GP’s lack of knowledge of the condition.

You may be struggling with your symptoms due to under treatment of your deficiency.

You may be buying supplies from another country due to lack of treatment from your GP.

You may however, be in the enviable position of being allowed to collect your prescribed ampoule from a chemist and have been taught by your GP Practice to self inject.

Whichever bracket you fall into, can you help?

Do you want to be able to buy B12 OTC from your pharmacy?

Do you want to be able to treat yourself when you need to, rather than when restrictive guidance allows?

NOW is the time to act, to take your future into your own hands and try with me to make B12 OTC.

Our Struggling NHS

The NHS was in trouble long before COVID 19 arrived, it’s been under funded and under threat for a long time. We can all help to make a difference!

As stated in my previous blog there are estimated to be 5.7 million people with B12 deficiency in the UK, which is greater than the population of Finland!

The cost of mental health

Obviously B12 deficiency affects all body systems but lets just focus on mental health as an example.

Each GP appointment costs on average £30 say NHS England with 40% of appointments now involving mental health.

According to the Children’s Society UK there are said to be 16 million people, that’s 1 in 4 of us who will experience a mental health issue at some point in our lives and “the estimated costs of mental health problems in the UK are over £100 billion each year.”

Given that depression and anxiety are common first presenting symptoms of B12 deficiency then it could be that a considerable proportion of this figure may have this very common, easily and inexpensively treated, but commonly misdiagnosed condition.

The NHS state that an under estimate of 49,988 people were detained under the Mental Health Act in the UK between 2018-2019. The cost of an overnight stay on a psychiatric ward is said to be around £400, that’s almost £20,000,000 per night! but clearly this is not the whole financial picture.

The numbers

If just 1% of the 5.7 million people suffer with poor mental health caused by B12 deficiency and are sectioned and detained for 30 days under the Mental Health Act then the cost to the NHS is at the very least £684 million.

Of those thought to be B12 deficient in the UK, consider that if just 0.001% which is 57 people, each had a 30 day section, this would cost at the very least £684,000.

By comparison, if each of those 57 people were able to have a weekly B12 injection, even at the current cost to the NHS which is £8.80 per box of 5 ampoules, (£1.76 each), then each person’s cost per year would be only £91.52. So the cost for 57 people just £5,216.64.

I personally know 4 people who have had extended stays in mental health units averaging 4 months. Each of these people are B12 deficient, two were sectioned prior to diagnosis and two were sectioned when on restricted 3 monthly B12 injections. Three of them now self treat by buying online at a cost of around 60p per ampoule and are now doing really well. But how long will we be able to buy from online pharmacies with Brexit looming?

The cost of just one of these people hospitalised for 4 months reaches at least £48,000. These figures are of course a gross under estimate of the actual cost of a section under the Mental Health Act. At the very least the cost of the initial assessment and the time of 2 doctors required for detainment would need to be added. And in some cases there might be the cost of an ambulance and its team, the police, a social worker, a Crisis Team, and sometimes even a locksmith.

This of course can never reflect the impact of the emotional cost to the person detained, to their family and friends, their personal financial losses, their inability to work, potential loss of career, continued need for mental health support and the wider cost to society as whole.

Get involved!

Will you help?

This interactive tool from the Go Compare Bill of Health explained by Net Doctor allows you to add up your own cost and contribution to the NHS.

Consider calculating your B12 deficiency related costs and emailing any of the following with your B12 story and why you think injectable B12 should be made available over the counter, as it is in many countries in Europe and around the world:

The MHRA – engagement@mhra.gov.uk 
Your MP – Find your MP’s email address
The health minister – matt.hancock.mp@parliament.uk
The chief medical Advisor – c.whitty@nhs.net

You could also email marie.turner@dhsc.gov.uk. Marie wrote to me from;

The Department of Health and Social Care which in their words “helps people to live more independent, healthier lives for longer. It leads, shapes and funds health and social care in England, making sure people have the support, care and treatment they need, with the compassion, respect and dignity they deserve.”

Marie wrote;

“Ms Witty has corresponded with the Department on this subject over a number of years, and it may help if I summarise the advice we have provided to her over this time…….

Ms Witty believes there are fundamental problems with the diagnosis and treatment of vitamin B12 deficiency and pernicious anaemia. When vitamin B12 deficiency has caused anaemia, its diagnosis is not generally difficult, and the Department is not aware of significant problems of under-recognition.”

Obviously the age old problem of incorrectly assuming anaemia is always present with B12 deficiency rears it’s ugly head in this letter, but it’s the bold text I’d like you to write to Marie about because she needs to know that as we are fully aware, B12 deficiency is absolutely under recognised, under treated and continually misdiagnosed to the detriment of the NHS and society as a whole.

If you need a little help with your email please find sample text here.

Your voice matters!

Best wishes,

Tracey
www.b12deficiency.info

Please consider signing and sharing the B12 OTC Petition.
PLEASE NOTE make sure you don’t pay to sign, the money goes to Change.org and not to the cause you are supporting.